Savara Inc. Reports $26.6 Million Net Loss in Q1 2025, Submits BLA for MOLBREEVI

Savara Inc. reported a net loss of $26.6 million for the first quarter of 2025, compared to a net loss of $20.3 million for the same period in 2024, reflecting an increase of approximately 31% year-over-year. The company's total operating expenses rose to $28.4 million, up from $22.5 million in the prior year, driven primarily by a 14% increase in research and development expenses, which reached $19.2 million. General and administrative expenses also saw a significant rise, increasing by 64% to $9.2 million, attributed to higher personnel costs and commercial activities.

As of March 31, 2025, Savara's cash and cash equivalents stood at $19.6 million, with short-term investments totaling $152.9 million. This represents a decrease in total current assets from $202.1 million at the end of 2024. The company’s accumulated deficit has grown to approximately $515.9 million, indicating ongoing financial challenges as it continues to invest heavily in its clinical development programs without generating revenue. The increase in cash used in operating activities, which amounted to $27.2 million for the quarter, underscores the company's reliance on external funding to sustain its operations.

In a strategic move, Savara completed the submission of its Biological License Application (BLA) for its investigational inhaled biologic, MOLBREEVI, to the FDA in March 2025. This product is in Phase 3 development for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The company previously reported positive results from its pivotal IMPALA-2 trial, which demonstrated significant clinical benefits. Additionally, Savara entered into a Loan and Security Agreement with Hercules Capital, allowing for up to $200 million in term loans, with an initial draw of $30 million used to repay prior obligations and support general corporate purposes.

Operationally, Savara has not yet commenced commercial operations and continues to focus on its sole product candidate, MOLBREEVI. The company has outsourced most of its manufacturing and clinical operations, which it expects will lead to significant additional expenses in the future. As of the end of the first quarter, Savara had approximately 216 million shares outstanding, reflecting an increase in the weighted average shares due to stock options and restricted stock units. The company anticipates that it will need to raise additional capital to fund ongoing development and potential commercialization activities, as it has not generated any revenue from product sales to date.